NCT02071303

Brief Summary

The purpose of this study is to compare the effectiveness of Tramadol and Celecoxib in reducing pain during outpatient hysteroscopy. Women undergoing outpatient hysteroscopy in Cairo university will be divided into 3 groups, the first group will receive Tramadol 100 1 hour before the procedure, the second group will receive Celecoxib 200mg 1 hour before the procedure and the third will receive a placebo. Pain will be assessed by a visual analogue scale.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2 pain

Timeline
Completed

Started May 2014

Shorter than P25 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 5, 2015

Status Verified

December 1, 2014

Enrollment Period

6 months

First QC Date

February 23, 2014

Last Update Submit

December 31, 2014

Conditions

Pain

Keywords

PainHysteroscopyTramadolCelecoxib

Outcome Measures

Primary Outcomes (1)

  • Pain perception during the procedure

    Pain will be assessed using a visual analogue scale 10 minutes after inserting the hysteroscope.

    10 minutes after starting the procedure.

Secondary Outcomes (1)

  • Pain perception after the procedure

    30 minutes after the procedure.

Study Arms (3)

Tramadol

ACTIVE COMPARATOR

Women will receive Tramadol 100mg 1 hour before the procedure.

Drug: Tramadol

Celecoxib

ACTIVE COMPARATOR

Women will receive Celecoxib 200mg 1 hour before the procedure.

Drug: Celecoxib

Placebo

PLACEBO COMPARATOR

Women will receive a placebo 1 hour before the procedure.

Drug: Placebo

Interventions

TramadolDRUG

Tramadol 100mg will be given to 70 women before the procedure.

Tramadol
CelecoxibDRUG

Celecoxib 200mg will be given to 70 women before the procedure.

Celecoxib
PlaceboDRUG

A placebo will be given to 70 women before the procedure.

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women referred to the outpatient hysteroscopy in Cairo university hospitals
  • Consent to the procedure

You may not qualify if:

  • Premenstrual patients
  • Patients with missed periods
  • Known cardiac disease
  • Known gastritis or peptic ulcer
  • Known allergy to Tramadol or Celecoxib

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

Location

Related Publications (5)

  • Sharma JB, Aruna J, Kumar P, Roy KK, Malhotra N, Kumar S. Comparison of efficacy of oral drotaverine plus mefenamic acid with paracervical block and with intravenous sedation for pain relief during hysteroscopy and endometrial biopsy. Indian J Med Sci. 2009 Jun;63(6):244-52.

    PMID: 19602758BACKGROUND

  • van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB, Jansen FW. Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review and meta-analysis. BJOG. 2007 Jun;114(6):664-75. doi: 10.1111/j.1471-0528.2007.01326.x.

    PMID: 17516956BACKGROUND

  • O'Flynn H, Murphy LL, Ahmad G, Watson AJ. Pain relief in outpatient hysteroscopy: a survey of current UK clinical practice. Eur J Obstet Gynecol Reprod Biol. 2011 Jan;154(1):9-15. doi: 10.1016/j.ejogrb.2010.08.015.

    PMID: 20926175BACKGROUND

  • Mathew ST, Devi S G, Prasanth VV, Vinod B. Efficacy and Safety of COX-2 Inhibitors in the Clinical Management of Arthritis: Mini Review. ISRN Pharmacol. 2011;2011:480291. doi: 10.5402/2011/480291. Epub 2011 May 17.

    PMID: 22084715BACKGROUND

  • Hassan A, Wahba A, Haggag H. Tramadol versus Celecoxib for reducing pain associated with outpatient hysteroscopy: a randomized double-blind placebo-controlled trial. Hum Reprod. 2016 Jan;31(1):60-6. doi: 10.1093/humrep/dev291. Epub 2015 Nov 29.

    PMID: 26621854DERIVED

MeSH Terms

Conditions

Pain

Interventions

TramadolCelecoxib

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsBenzenesulfonamidesSulfonamidesAmidesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • AbdelGany MA Hassan, MRCOG, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Gynecology and Obstetrics

Study Record Dates

First Submitted

February 23, 2014

First Posted

February 25, 2014

Study Start

May 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

January 5, 2015

Record last verified: 2014-12

Locations

EG(1)